FDA-RFI-126534.pdf

Statement of Work

Statement of Work (Nfusion Annual Subscription Service) Page 1

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

Nfusion Subscription Service (or equal)

1.0 Background

The Office of Criminal Investigations (OCI) serves as the Food and Drug Administration’s (FDA) criminal law enforcement arm. OCI protects the American public and supports the agency mission by conducting criminal investigations of illegal activities involving FDA-regulated products.

Serious crimes investigated by OCI include but are not limited to:

• Counterfeit, misbranded, or unapproved human and animal drugs and prescription medical devices

• Tainted dietary supplements

• Foodborne illness outbreaks or contaminations

• Product tampering or substation

• Application and clinical trial fraud

• Fraudulent health treatments

• Counterfeit tobacco products, including electronic cigarettes

• Internet pharmaceutical trafficking networks

A critical component of the OCI is cyber operations. The Cyber Operations Division within the OCI is comprised of a Cybercrime Investigative Unit, Digital Forensics Unit, and a Technical Support Branch.

This requirement directly supports the Cyber Operations Division.

The Cyber Operations Division currently leverages Nfusion by Ntrepid Corporation to facilitate secure and anonymous online research and investigations. Currently, the Nfusion solution is fully deployed on criminal investigator and intelligence analyst workstations. Nfusion is a comprehensive virtual environment for conducting and managing online research and investigations without being detected by websites using sophisticated tracking techniques, such as browser fingerprinting and IP address tracing.

This solution replaces “stand-alone” computers deployed in the field that required constant maintenance and costly software and hardware updates. Nfusion eliminates the requirement to service these stand-alone computers and removes the need for independent wired and wireless access at OCI offices.

1.1 Objective

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

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The primary objective is to procure 25 concurrent subscription licenses for up to 175 OCI users, on a firm fixed price basis, for the Nfusion Annual Subscription Service and Geo Site Access, brand name or equal.

This will enable OCI investigators the ability to conduct online investigations without being detected by websites using sophisticated tracking techniques, such as browser fingerprinting and IP address tracing.

2.0 Requirements / Deliverables

The Contractor shall provide the Nfusion Annual Subscription Service and Geo Site Access, brand name or equal, as delineated in the table below. OCI requires up to 175 users to have access to the solution, however no more than 25 users shall be concurrently logged into the system at one time.

2.1 Deliverables

Item # Product (Equivalent Item #) Product Description Qty Period of

Performance

Nfusion Annual Subscription Service and Geo Site Access

Equivalent Item Numbers:

NFU-CU-5-HOST/NFU-CU-1-HOST and

LG1-01

Concurrent Licenses and Maintenance/Technical

Support

Base:

09/14/2025 - 09/13/2026

Nfusion Annual Subscription Service and Geo Site Access

Equivalent Item Numbers:

NFU-CU-5-HOST/NFU-CU-1-HOST and

LG1-01

Concurrent Licenses and Maintenance/Technical

Support

Option Year 1:

09/14/2026 - 09/13/2027

Nfusion Annual Subscription Service and Geo Site Access

Equivalent Item Numbers:

NFU-CU-5-HOST/NFU-CU-1-HOST and

LG1-01

Concurrent Licenses and Maintenance/Technical

Support

Option Year 2:

09/14/2027 - 09/13/2028

Nfusion Annual Subscription Service and Geo Site Access

Equivalent Item Numbers:

NFU-CU-5-HOST/NFU-CU-1-HOST and

LG1-01

Concurrent Licenses and Maintenance/Technical

Support

Option Year 3:

09/14/2028 - 09/13/2029

Nfusion Annual Subscription Service and Geo Site Access

Equivalent Item Numbers:

NFU-CU-5-HOST/NFU-CU-1-HOST and

LG1-01

Concurrent Licenses and Maintenance/Technical

Support

Option Year 4:

09/14/2029 - 09/13/2030

Statement of Work (Nfusion Annual Subscription Service) Page 3

2.2 Salient Characteristics

The Contractor shall ensure salient characteristics for the Nfusion Subscription Service and Geo Site Access, or equal are provided as cited below. If an alternate solution is proposed, the Contractor shall ensure the proposed solution shall meet or exceed the following functionality.

• Solution shall provide malware immunity needed to protect FDA’s network and IT assets from malware contagion and defy all malicious content through the use of a virtual machine.

• Solution shall be a virtual desktop solution.

• Provide a non-attributable secure desktop and browser, including TOR browser, that resets itself every time a user logs in to prevent browser fingerprinting through unique browser sessions. The system shall also provide the user the option to have their browser settings stay stagnant so as to appear as the same user when they log back into the system.

• Solution shall stop passive information leakage through secure storage.

• Solution shall provide at least seven (7) US, (2) Canadian and (5) Global/foreign IP hubs to control a particular geo-location on the fly.

• Solution shall backstop IP hubs to prevent attribution to FDA or Government.

• Solution shall provide the OCI managers with comprehensive oversight and analytics of user activity to include logs listing user activity, sites visited and login information.

• Solution shall enable investigators to conduct and manage online research and investigations without being detected by websites.

• Solution shall use tracking techniques to include browser fingerprinting, and IP address tracing.

• Shall Allow investigators to print and copy and paste data directly onto the secure browser.

• Solution shall allow users to download and upload files securely and without threat of malware contagion. Downloaded files shall be scanned for viruses prior to down onto FDA computers.

• Solution shall allow users to print and copy and paste data directly onto the secure browser.

• Solution shall allow for FDA administrator control. The administrator control shall allow for an

FDA administrator to be identified and said administrator has the ability to create and delete FDA user accounts as well as have the ability to monitor FDA user activity.

• Solution shall be ready, “off-the-shelf” and not require customization prior to meeting the requirements of this SOW.

• Solution shall be compatible with the relevant FDA/OCI IT infrastructure which is Windows operating systems and VPN and/or Zscaler.

• Quoter shall be authorized by the Original Equipment Manufacturer (OEM) to offer the brand name solution in response to this solicitation.

The Contractor shall also provide solution maintenance and technical support equal to the following:

• Solution shall include maintenance and technical support for the duration of performance.

Maintenance and technical support shall include patches, updates/refreshes/new versions. Any patch, update, refresh shall be made available as soon as commercially available. Further, the Contractor shall assist users with log-on issues, system navigation, query submittals, as well as provide users with FAQ’s, tutorials, and best practice guides for use.

• Solution shall provide maintenance and technical support during the following business hours:

8:30a.m. to 5:00 p.m., Eastern Time (ET), Monday through Friday, with the exception of Government holidays.

• Solution shall provide technical support via telephone, email, and/or web.

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2.3 Compatibility:

• The solution shall be compatible with the relevant FDA/OCI IT environment, which is a Windows operation systems and VPN and/or Zscaler.

(Please note, FDA defines “compatible” as meaning there will be no communication, performance, legacy data recovery, or maintainability issues of solutions with differing brand names.)

3.0 FOB Point Destination

• All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation completed within 30 days after receipt of order.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

• Business name, UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm);

• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including technical specifications, descriptive material, literature, brochures, and other information, which demonstrates the capabilities of the contractor to meet the requirement.

• Three (3) years of past performance information for the manufacture, and/or sale and support in which the offeror has provided same or substantially similar products and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include UEI number and size status) if not the respondent.

• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

• If a large business, identify the subcontracting opportunities that would exist for small business concerns;

• Standard commercial warranty and payment terms; and

• Though this is not a request for quote, informational pricing is encouraged.

• The government is not responsible for locating or securing any information, not identified in the response.

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• The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

• Interested Parties shall respond with capability statements on or before 4/25/2025, by 1:00 pm Eastern Time (ET).

Notice of Intent

Responses to this source sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on Sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

4.0 Government Points of Contacts

Contracting Officer (CS):

Robert Waite Robert.Waite@fda.hhs.gov